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RecruitingPhase 2

TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

TIRO-AF: TIRzepatide for the Treatment of Obesity in Patients With Atrial Fibrillation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients who met the initial screening criteria (including presence of at least 1% AF burden during a 2 week monitoring period with an ambulatory cardiac monitor) will be invited for possible enrolment. 100 Patients will then be randomized 1:1 to Tirzepatide group versus placebo and will be followed for 12 months."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tirzepatide helps people lose weight and improves atrial fibrillation (AFIB), an uneven heartbeat, over 12 months. It is for adults ages 18–80 with AFIB symptoms and a body mass index (BMI) of 27–60. Participants will get either tirzepatide or a placebo, which has no active medicine.

This is a single center randomized double blind controlled study of patients (BMI ≥ 27 kg/m2) with obesity and Atrial Fibrillation (AFIB) randomized to Tirzepatide vs. placebo. It is expected that the significant weight loss with Tirzepatide will result in improved control, management, symptom severity, and burden of AFIB at 12 months.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–80 years old.
  • Have a BMI of 27–60. BMI is a measure of weight compared with height.
  • Have a normal heart rhythm when assigned to a study group, either ongoing or shown at an office visit.
  • Have AFIB with symptoms, confirmed by an ECG or heart monitor. AFIB must come and go or stay for longer periods.
  • Have no changes to diabetes medicines, including insulin, for at least 3 months before joining.
  • If you have type 2 diabetes, have an HbA1c of 10% or less. This blood test measures average blood sugar.
  • Be able and willing to give yourself the study medicine, follow study rules, and sign a consent form.

Who can't join

  • Had AFIB ablation, a procedure to treat the uneven heartbeat, in the past 6 months; plan it within 3 months after group assignment; or need heart valve treatment or surgery within 12 months.
  • Have severe uncontrolled heart or lung disease, class III or IV heart failure, or a heart pumping measure below 35%. Also excluded: a hospital stay in the past 6 months for a heart attack, unstable chest pain, stroke, mini-stroke, or heart surgery.
  • Have had an organ transplant; have type 1 or autoimmune diabetes; have kidney function below 30 or need dialysis; have advanced liver scarring with poor liver function; have liver enzyme levels above 300; or have hemoglobin, which carries oxygen in blood, below 9.
  • Have active cancer other than non-melanoma skin cancer, an expected lifespan under 3 years due to other illnesses, or another condition the study doctor thinks makes joining unsafe. Certain major mental health or substance use disorders also exclude people.
  • Are using an experimental treatment, are in another drug or device trial, or took part in one less than 3 months ago. Also excluded: use of GLP-1, DPP-4 inhibitor, or GIP/GLP-1 medicines now or within the past 6 months.
  • Have a personal or family history of pancreatitis (swelling of the pancreas), medullary thyroid cancer, or MEN2 (a condition that can cause tumors in hormone-making glands). Also excluded: an allergic reaction to the study medicine related to past use of the listed medicines, or an allergy to medical tape or adhesive.
  • Drink more than 2 alcoholic drinks a day on average, or plan to move away from Northeast Ohio within 12 months.
  • Are pregnant, breastfeeding, or planning to become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Subjects eligible for inclusion in this study must meet all of the following criteria: 1. Sinus rhythm at randomization 1. Sustained normal sinus rhythm (or) 2. Normal sinus rhythm at office visit 2. Age ≥18 to ≤80 years old 3. BMI ≥ 27 and ≤60 kg/m2 4. AFIB criteria: 1. Must be documented by ECG or monitor. 2. Must have symptomatic AFIB (Atrial Fibrillation). 3. In terms of types of AFIB, either paroxysmal AFIB or persistent AFIB. 5. All anti-diabetic medication (including insulin) must be stable for at least 3 months prior to enrollment, 6. HbA1c ≤10% for patients diagnosed with Type 2 Diabetes Mellitus (T2DM). 7. Ability and willingness to give themselves the medication, comply with study requirements and provide written informed consent. Exclusion Criteria: Subjects meeting any of the following criteria are not eligible for inclusion in this study. 1. AFIB ablation within the last 6 months 2. Planned ablation prior to 3 months post randomization 3. Significant cardiac valvular disease with planned cardiac valve intervention/surgery in the next 12 months 4. Severe uncompensated cardiopulmonary disease 5. New York Heart Association Class III or IV 6. Left ventricular ejection fraction \<35% at the time of screening 7. Hospitalization in the past 6 months for myocardial infarction, unstable angina, stroke, transient ischemic attack, or heart surgery 8. History of solid organ transplant 9. Type 1 diabetes mellitus or auto-immune diabetes 10. Estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m2 at screening or on dialysis 11. Advanced and decompensated cirrhosis characterized by: presence of fibrosis stage 4 (cirrhosis) in liver biopsy, ascites, hepatic encephalopathy, portal hypertension, or esophageal varices. 12. Hemoglobin less than 9 g/dL 13. Current participation or use of investigational therapy or less than 3 months since participation in any drug or device trial. 14. Liver transaminase level \>300 U/L 15. Subject reports alcohol use of on average \>2 drinks/day 16. Presence of active malignancy (except non-melanoma skin cancer) 17. Life expectancy less than 3 years due to concomitant diseases 18. Major mental health, psychological disorders, or substance abuse disorders that could disqualify the patient from metabolic surgery 19. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study 20. Plans to move outside the primary location of study (Northeast Ohio) within the next 12 months 21. Any personal or family history of pancreatitis or medullary thyroid cancer or MEN2 (Multiple Endocrine Neoplasia Type 2) 22. Current use or any use within the last 6 months of GLP-1/DPP4i (Glucagon-Like Peptide-1/Dipeptidyl Peptidase-4 inhibitor) or GIP (Gastric Inhibitory Polypeptide)/GLP-1 23. Known hypersensitivity to investigational product due to prior use of GLP-1/DPP4i or GIP/GLP-1 24. Allergy to medical grade tape or adhesive 25. Pregnant, breast-feeding or plans to become pregnant

Study sites (1)

OH